Cleared Traditional

K922398 - 4 SURE TM ENEMA BAG SET

K922398 is an FDA 510(k) clearance for 4 SURE TM ENEMA BAG SET, manufactured by Boston Pacific Medical, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FCE cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K922398 · Boston Pacific Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
392d
Days
Class 1
Risk

K922398 is an FDA 510(k) clearance for the 4 SURE TM ENEMA BAG SET. Classified as Enema Kit (product code FCE), Class I - General Controls.

Submitted by Boston Pacific Medical, Inc. (Boston, US). The FDA issued a Cleared decision on June 17, 1993 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5210 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Pacific Medical, Inc. devices

FDA 510(k) Submission Details - K922398

510(k) Number K922398 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received May 21, 1992
Decision Date June 17, 1993
Days to Decision 392 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
261d slower than avg
Panel avg: 131d · This submission: 392d
Pathway characteristics
Predicate-based equivalence.

FCE Device Classification - Class 1, General Controls

Product Code FCE Enema Kit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5210
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html.this Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FCE Enema Kit

All 9
Devices cleared under the same product code (FCE) and FDA review panel - the closest regulatory comparables to K922398.
AMSURE CLEANSING ENEMA SET
K974042 · Amsino Intl., Inc. · Dec 1997
ENEMA BUCKET SET
K901179 · Orion Life Systems, Inc. · Jun 1990
ENEMA BAG SET
K901182 · Orion Life Systems, Inc. · Jun 1990
LARGE VOLUME ENEMA CONTAINER DISPOSABLE
K800959 · The Healthcare Group Laboratories, Inc. · May 1980
1500 ML DISPOSABLE ENEMA CONTAINER(1110)
K800960 · The Healthcare Group Laboratories, Inc. · May 1980
ENEMA CONTAINER DISP. FOR EMEMA ADMIN.
K800961 · The Healthcare Group Laboratories, Inc. · May 1980